RESUMEN
BACKGROUND: For patients with atrial fibrillation and a prior stroke or transient ischemic attack (TIA), the risk-benefit of direct oral anticoagulants (DOACs) compared to alternative treatment approaches has not been firmly established. We conducted a systematic review of randomized controlled trials (RCTs) to investigate efficacy and safety of DOACs vs warfarin and DOACs vs aspirin or placebo in patients with AF and a prior stroke or TIA. METHODS: We searched PubMed, EMBASE, and Cochrane Central Register of Controlled Trials from January 1, 2000, to January 31, 2023, to find RCTs. Risk ratio (RR) with 95 % CI measured the association of DOACs vs warfarin, and DOACs vs aspirin or placebo, with clinical outcomes. Primary efficacy outcome was stroke or systemic embolism and primary safety outcome was ICH. RESULTS: We identified 7 RCTs with 19,111 patients with AF and a prior stroke or TIA, of which 5 trials compared DOACs with warfarin and 2 trials compared DOACs vs aspirin or placebo. Compared with warfarin, DOACs were associated with a lower risk of stroke or systemic embolism (RR, 0.85; 95 % CI, 0.75-0.97) and ICH (RR, 0.53; 95 % CI, 0.41-0.68). Compared with aspirin or placebo, DOACs were associated with a reduced risk of stroke or systemic embolism (RR, 0.33; 95 % CI, 0.19-0.58) and risk of ICH did not differ between apixaban and aspirin. CONCLUSIONS: This contemporary evaluation of the literature indicates that DOACs, rather than other antithrombotic agents or no treatment, should be used in patients with AF and a prior stroke or TIA.